FDA UDI
In Commercial Distribution
🇺🇸 United States
rbi2 suction rectal biopsy system
DI: B194MR1001
·
Model: rbi2
·
AUS SYSTEMS PTY. LIMITED.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- rbi2 suction rectal biopsy system
- Primary DI
- B194MR1001
- Version / Model
- rbi2
- Catalog Number
- MR100
- Company Name
- AUS SYSTEMS PTY. LIMITED.
- Labeler DUNS
- 755219508
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-29
- Public Version
- 4
- Public Version Date
- 2020-11-24
- Public Version Status
- Update
- Public Device Record Key
- 7398e368-5d22-4364-bd4d-9aeaff4e45d1
Device Description
rbi2 suction biopsy system negative pressure manometer
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FCK | Instrument, Biopsy, Suction | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58392 | Rectal suction biopsy system | An assembly of disposable and reusable devices designed to obtain a submucosal tissue specimen from the rectum using suction [rectal suction biopsy (RSB)], typically for histopathological analysis [e.g., to help diagnose Hirschsprung's disease (HD)]. It typically consists of dedicated disposable capsules (e.g., plastic cylinder-shaped devices with a small hole at their closed end that contain a metallic cutting blade), suction tubing with negative pressure manometers, and a reusable handpiece. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B194MR1001 | HIBCC | ||||
| Package | B194MR1002 | HIBCC | Box | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062159 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry